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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Water Purification
510(k) Number K080703
Device Name BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK
Applicant
4m Ventures, Inc.
1415 Halsey Way, Suite 304
Carrollton,  TX  75007 -4455
Applicant Contact DENICE GALLAGHER
Correspondent
4m Ventures, Inc.
1415 Halsey Way, Suite 304
Carrollton,  TX  75007 -4455
Correspondent Contact DENICE GALLAGHER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received03/12/2008
Decision Date 06/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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